MSAT Scientist III, Upstream
Core
Lead technology transfer, process validation, and manufacturing support for upstream cGMP viral vector production.
Role type
Senior Manufacturing Sciences Scientist (Upstream)
Builds
Late-stage clinical and commercial gene therapy vector products
Domain
Biopharmaceutical manufacturing / Cell and Gene Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Upstream biopharmaceutical manufacturing, Process development, Technology transfer, Process validation, GMP compliance, Root cause analysis, CAPA implementation, Equipment qualification, Sampling plan design, Process monitoring and trending
Preferred skills
Adherent mammalian cell culture (HEK), Stirred tank and single-use bioreactors, Flat stock technology (Cellstacks, Hyperstacks, iCellis), Late-stage/commercial scale-up, Cell and gene therapy vector production
Technologies
Stirred Tank Bioreactors, Single-use Bioreactors, Cellstacks, Hyperstacks, iCellis
Responsibilities
Lead technology transfer for upstream cGMP manufacturing; Collaborate on process transfer and scale-up; Author process definition, risk assessment, and PPQ protocols; Monitor process performance and investigate deviations; Support engineering teams on equipment selection and qualification.
Seniority
Senior, hands-on IC
